committee: - ministry of health web viewms thomas noted standard treatment was combination...

Minutes

Committee: Northern B Health and Disability Ethics Committee

Meeting date: 01 October 2013

Meeting venue: CEO Meeting Room, L3, Hocking Building, Waikato Hospital Campus

Time Item of business

12.00pm Welcome

12.05pm Confirmation of minutes of meeting of 03 September 2013

New applications (see over for details)12.30-1.001.00-1.301.30-2.002.00-2.302.30-3.003.00-3.303.30-4.00

i 13/NTB/143ii 13/NTB/144iii 13/NTB/145iv 13/NTB/146v 13/NTB/147vi 13/NTB/148vii 13/NTB/151

3.30pm General business: Noting section of agenda

3.37pm Meeting ends

Member Name Member Category Appointed Term Expires Apologies?Mrs Raewyn Sporle Lay (the law) 01/07/2012 01/07/2015 Present

Mrs Maliaga Erick Lay (consumer/community perspectives)

01/07/2012 01/07/2014 Present

Mrs Mary Anne Gill Lay (consumer/community perspectives)

01/07/2012 01/07/2015 Apologies

Mrs Kate O'Connor Non-lay (other) 01/07/2012 01/07/2015 Present

Mrs Stephanie Pollard Non-lay (intervention studies) 01/07/2012 01/07/2015 Present

Dr Paul Tanser Non-lay (health/disability service provision)

01/07/2012 01/07/2014 Present

Ms Kerin Thompson Non-lay (intervention studies) 01/07/2012 01/07/2015 Present

HDEC Minutes – Northern B Health and Disability Ethics Committee – 01 October 2013 of 19

Welcome

The Chair opened the meeting at 12.09pm and welcomed Committee members, noting that apologies had been received from Mrs Mary Anne Gill.

The Chair welcomed David Stephens for lunch and thanked him for his time on the Committee, noting his resignation from the Northern B Ethics Committee. David expressed his enjoyment from being on the Committee and thanked the Chair.

The Chair welcomed Kelly Traynor to the HDEC Secretariat.

The Chair noted that the meeting was quorate.

The Committee noted and agreed the agenda for the meeting.

Confirmation of previous minutes

The minutes of the meeting of 3 September 2013 were confirmed.


New applications

1 Ethics ref: 13/NTB/143Title: Effectiveness and Safety of FG-4592 for the treatment of

anaemia in people with CKD not on dialysisPrincipal Investigator: Dr David M. VossSponsor: FibrogenClock Start Date: 18 September 2013

Dr Saib Abbas (Co-investigator) and Ms Catherine Howie (Primary Contact) were present by teleconference for discussion of this application.

Potential conflicts of interest

The Chair asked members to declare any potential conflicts of interest related to this application.

No potential conflicts of interest related to this application were declared by any member.

Summary of ethical issues

The main ethical issues considered by the Committee were as follows.

The Committee noted that the Patient Information Sheet and Protocol were well written and easy to understand.

Catherine Howie queried whether an interpreter box was a requirement for the Consent Form noting the HDEC had changed the template PIS/CF. The Committee explained if a study does not involve an option for an interpreter the study may unfairly exclude potential participants which is against the Code of Rights which requires equal access to participate in research.

Dr Abbas explained that it is often the case that the participants can speak English, as well as citing limited resources for some studies. Dr Abbas sought clarification on whether they have to advertise having an interpreter. The Committee suggested that depending on the options available to participants in the study it is reasonable to ensure the Patient Information Sheet is explicit. Therefore if interpreters would be available, considered, or if an interpreter will not be available it should be stated. The researchers agreed this would be a suitable option.

The Committee queried if informing a participant’s GP of study involvement is optional or mandatory (R.1.2). Researcher clarified the GP will be informed in all cases.

The Committee noted the trial Co-ordinator was recruiting participants. The Committee asked how the potential conflict of interest would be mitigated, as the trial co-ordinator has a vested interest in recruiting participants into the trial. The Committee suggested giving patients time to consider study involvement outside of the clinic environment. Ms Howie confirmed this measure was already in place.

The Committee discussed giving potential participants the option of talking about study involvement with a person outside of the study. The Committee noted the Patient Information Sheet had evidence that participants have the option to discuss participation with independent parties such as Maori health contacts and disability services.


The Committee asked the Researcher to ensure the ethnicity data collection on the Participant Information Sheet is appropriate for a New Zealand context (P.4.6). The Committee suggested using the New Zealand Census question for guidance.

Ms Howie explained that because this information is going to the sponsor it is not likely that they will do anything useful with this information. The Committee explained that the data collection should be conducted in a manner appropriate for a New Zealand context, even if the data is not utilised. The Researcher agreed it would be useful to have the information.

The Committee queried the degree of independence of the Data Safety Monitoring Committee (R.1.5). Ms Howie was not able to answer the question, noting the sponsor would be best placed to answer this.

Please confirm that results made available to participants will be in lay language (P.2.9). Ms Howie stated she would follow up with sponsor to confirm.

The Committee queried if Maori consultation had begun. The researcher explained that locality approval involved Maori consultation and would be conducted and approved before the study is started at each locality.

The Committee noted that the sponsor’s certificate of liability expires at the end of the year. Ms Howie advised that she will notify the sponsors of this.

The Committee requested the following changes to the Participant Information Sheet and Consent Form:

o Please define ‘placebo’ in lay language.o Make it clear that GP will be informed of study involvement.o On Page 1 there is a spacing typo ‘Doctor’.o On Page 5 please remove reference to Federal Law.o On Page 9 please remove terminating the study for commercial interests.

Studies should not be terminated simply for reasons of commercial interest or public relations (Ethical Guidelines for Intervention Studies, para 6.65).

Decision

This application was provisionally approved by consensus, subject to the following information being received.

Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22).

Clarify the independence of the Data Safety Monitoring Committee (Ethical Guidelines for Intervention Studies para 6.50).

Confirm study participants will receive a lay language summary of the study findings (Ethical Guidelines for Intervention Studies para 6.22).

The above information will be reviewed, and a final decision made on the application, by Dr Paul Tanser and Mrs Mali Erick


2 Ethics ref: 13/NTB/144Title: Aspiration therapy for treating obesityPrincipal Investigator: Dr Dinesh LalSponsor: New Zealand Medical and ScientificClock Start Date: 19 September 2013

Dr Dinesh Lal (Co-ordinating Investigator) and Dr Geogry Peter Kini (Co-investigator) were present by teleconference for discussion of this application.

Note there were technical difficulties with the connection and much of the communication was not clear.






The Committee queried if being pregnant during the study would pose risks. The Researchers noted that the study protocol publication had been accepted in America.

This New Zealand study uses the same protocol. The Committee queried why the study was being conducted in New Zealand when it had already been done in America.

The Committee queried the risks involved for participants, noting the supporting documents state that patients have a risk of fluid going into the lungs when the patients cough, while water is being infused (being put into the stomach). The researcher stated that this is not true, adding that the intervention is already approved overseas. The procedure is very similar to what we do for patients who have difficulty eating and need assistance.

The committee asked if the statement was relevant for participants. The Researcher explained that if a participant did cough during infusion there will be an increase in pressure from the diaphragm but it would not result in a substantial risk. The Committee queried if this risk would be discussed with participants. The Researcher confirmed all risks, including potential risks, would be discussed.

The committee queried the risks involved if participants gain weight while the PEG is installed.

The Researcher explained that if participants gain weight they are not compliant. The Committee queried whether the requirements for study participation were adequately communicated. The Researcher explained that when participants are offered the treatment they must understand that they need to be compliant. The device can be removed if participants gain weight.

Researcher re-stated it is important to make sure participants understand the conditions before taking part.

Please clarify how existing medication and doses are monitored in relation to patients who lose weight. The Researcher explained that patient selection would be important in this regard. There may be a small group of patients who are diabetic who will need to be closely monitored to ensure their medication is appropriately dosed as the patients lose weight. The screening process will attempt to reduce the number of patients who have pre-existing medical requirements but the committee felt that it was possible that patients


requiring future dose modifications could be recruited under current protocol and this would need to be monitored and managed even though the number of such patients may be limited.

The Committee queried the request to not take any medication during meal time. The researcher explained this was related to meal absorption. The window to not take medications would be between half an hour and at the most 2 hours.

The Committee requested all possible risks for participants to be recorded on the PIS/CF and where possible quantify the risks and advise of likely action needed should any such risk materialise, eg remove PEG.

The Committee would like more information in relation to the Data Safety Monitoring in place, noting that (R.1.5) in the application refers to monitoring of the participant, where the question is asking about the monitoring of data and oversight of trial.

The Committee would like further information on criteria to terminate the study, noting that (R.1.6) has been answered in relation to participants withdrawing, rather than study termination.

Please answer R.1.8 in relation to R.1.7. The answer is currently not related to whether the study is carried out principally for the benefit of the manufacturer or distributor of the medicine or item being trialed. Please explain why this study is not for the primary benefit of the manufacturer.

The Committee noted that in future applications the researcher only needs to upload questionnaires that will be going to the participants (R.2.3.2).

Clarify if data is anonymous or de-identified, during the study and afterwards. Please review the Guidelines for Intervention Studies for definitions of the various forms of data storage. (R.2.4).

Please justify retaining health information for less than 10 years (R.2.5). The Committee queried if there is an independent person the participant can talk to prior

to study participation to mitigate conflict of interest (R.5.4.1) Please explain how any cultural issues raised will be managed (P.4.2). Please explain what appears to be a ‘clinical trial exclusion’ in the insurance uploaded.

This is not sufficient cover for participants if the study is for primary benefit of the manufacturer.

The Committee queried the ethnicity data collection (P.4.6). The Committee suggested using the New Zealand Census question for guidance.


o Please explain what ‘aspiration therapy’ is in lay language.o The Committee suggested including a diagram to help participants understand

what is involved.o Please include explicit information about medication rules while PEG inserted.o Please make it clear that the study requires strict lifestyle rules in order to

comply with the study and to achieve weight loss.o Reconsider the time taken to discuss the study with participants (10 minutes

currently).o Use lay language and do not use complicated terminology and explain jargon

(Section 1 – page 1).o Explain ‘electrolyte imbalance’ and explain how this is to be managed. Clarify

what this means in terms of side effects (Section 3).


o Ensure the ACC statement contains all relevant information for participants, noting this may have to change if the study is for the primary benefit of manufacturer (Section 4).

o Please amend storage of health information (Section 6).o Please explain what is meant by ‘destroying data’ with reference to the

‘standard protocol’ – this is not clear for participants.o Include contact numbers for Maori health support (Pg.3).o Please confirm that the researchers are able to provide a translator (as

suggested in CF statement). Suggest rewording to ‘in a language that I can understand’ rather than in my first language’.

o Please clarify if participants who withdraw can have the device removed at no cost. Please explain the options clearly to participants.

Decision

This application was provisionally approved by [consensus/vote, with X for and Y against], and [name of member] dissenting], subject to the following information being received.

Please provide criteria for study termination. (Ethical Guidelines for Intervention Studies para 6.64).


Please address how cultural issues that may arise for participants in the study will be managed (Ethical Guidelines for Intervention Studies para 4.7).

Clarify if the study is for the primary benefit of the manufacturer (Standard Operating Procedures para 144)

Address the ethical issues raised above in a cover letter addressed to the Committee (Ethical Guidelines for Intervention Studies para 3.11)

Please provide valid clinical trials insurance certificate or confirm this is not for benefit of manufacturer.

The above information will be reviewed, and a final decision made on the application, by Ms Kerin Thompson and Ms Mary-Anne Gill.


3 Ethics ref: 13/NTB/145Title: The Dynamic Patterns of Thinking in

Attention-Deficit/Hyperactive Disorder (ADHD)Principal Investigator: Dr Fabian Labra-SprohnleSponsor:Clock Start Date: 19 September 2013

Dr Fabian Labra-Sprohnle (Co-ordinating Investigator) and Dr Garth Smith (Co-Investigator) were present by teleconference for discussion of this application.






The Committee noted the concept was interesting and a diagnostic tool that was child friendly was a commendable goal.

The Committee noted the application was difficult to read citing internal consistency as lacking.

The Committee queried whether the participants were children who had been diagnosed with ADHD or were potentially ADHD (B.2.1). The Researchers explained that recruitment was a two-step process. Children who are referred to a clinic with behavioural problems would undergo standard clinical assessment to diagnose ADHD. The children will be invited to take part in the trial before treatment for ADHD is started and will be measured against a control group.

The Committee queried why the questionnaire is being sent out before the participants consent to study involvement or are diagnosed with ADHD.

The Committee explained that the participants are very vulnerable, being children as well as undergoing assessment for a mental health diagnosis. The Committee suggests recruiting after the ADHD is confirmed noting it is not appropriate for the participants to be recruited on their first clinic visit.

The Researcher explained the difficulty of having to recruit participants who had ADHD without being on medication or undergoing treatment, as treatment would affect the study results. The Researcher added the need to avoid holding up standard treatment for the children.

The Committee queried the number of visits involved for participants. The researcher clarified that the study involves one session. The protocol with three visits is outdated. The Committee requested up to date documents be sent for review.

The Committee noted Maori consultation was pending. The Committee queried how long the game session lasts for participants, noting the

different times cited in the supporting documents. The researcher expressed difficulty in providing accurate expected times due to the children’s varied ability. The Committee suggested including a range.

In future applications please ensure plain English is used and avoid the use of jargon. If jargon needs to be used please explain it in plain English.


Please explain whether an age appropriate Patient Information Sheet will created for younger participants.

The Researcher explained that there was a PowerPoint presentation that was going to be used to explain the study to children participants. The Committee noted this would need to be submitted for review before use.

The Committee queried how the control children would be recruited. The Researcher stated that the recruitment would involve internal notices intended for hospital staff. The Committee noted that any advertising and information provided to the control group needs to come before the Committee for approval.

The Committee queried how the study was controlling for variables between children noting the peer review raised several issues about executive functioning related to other domains and the issue of varied skill in playing video games. The Researcher explained they were not controlling for skill but were controlling for age, sex, ethnicity and level of instruction. The Committee asked why there were IQ exclusion criteria. The Researcher stated this was outdated and they were not controlling for IQ.

The Committee queried how ethnicity would be collected. The researcher clarified the parents would provide this information. The Committee suggested using the NZ Census question as a template to collect ethnicity data.

The Researcher explained that the study was focused on diagnostic outcomes rather than population data. The Committee asked how the study will reduce health inequalities as stated on the application if the study did not accurately record relevant data. The Researcher stated that diagnostic outcomes and population data are both important but that the study was focused on assessing the tool.

The Committee noted there were no inclusion criteria for the control group. The Researcher explained that the Maori research protocol that was uploaded with the

supporting documents is very outdated. The Committee noted that if the documents submitted were not up to date it makes reviewing the application very difficult.

Please make it explicit that participation in the study is voluntary. Separate CF from assent form The Committee requested the points raised in the peer review be addressed and

requested a signed copy of the peer review document to be submitted. Please include a space for the researcher to sign the PIS/CF The Committee noted the following documents were not supplied:

o Child appropriate Patient Information Sheeto PowerPoint Presentationo Advertisements for control group


o Please be clear about time requirements involved for participants including the time taken to conduct the intervention.

o Be explicit that data matching will occur with the child’s existing medical records.

o Detail the HDEC which reviewed the study including contact information.o Include the contact details for the Health and Disability Advocacy group.o Include contact details for researchers involved in the study.o Be clear about the number of visits required for study participation.o Include the exclusion and inclusion criteria.


Decision

This application was declined by consensus as the Committee did not consider that the study would meet the following ethical standards.

Insufficient information to adequately review the informed consent process (Ethical Guidelines for Intervention Studies para 6.22).

There is a lack of processes in place to mitigate risk of recruitment in a vulnerable context (Ethical Guidelines for Intervention Studies para 6.2).

There is insufficient information on the control group (Ethical Guidelines for Intervention Studies para 2.8).


4 Ethics ref: 13/NTB/146Title: (ANZ 1201 / BIG 6-11) NeoPHOEBE: Pi3k inhibition in Her2

OverExpressing Breast CancErPrincipal Investigator: Dr Marion Kuper-HommelSponsor: Novartis Pharmaceuticals Australia Pty LtdClock Start Date: 19 September 2013

Ms Wendy Thomas, the Charge Nurse Manager for the Cancer Trials Unit was present in person for discussion of this application.



Ms Kerin Thompson declared a potential conflict of interest. The Committee decided the conflict was not significant and the member could take part in the discussion of the application as well as take part in the decision.



Ms Thomas told the Committee she felt the PIS/CF could be improved regarding the information on standard of care. Ms Thomas had contacted the Sponsor to request including more detailed and accurate information on standard of care in New Zealand. The Sponsor declined the request for changes citing the protocol being an international standard protocol.

The Committee queried standard practice in New Zealand. Ms Thomas noted standard treatment was combination trastuzumab and paclitaxel of between 12-18 weeks. This differs from the outline in the information sheet for participants. The Committee noted the current PIS/CF is misleading In particular, the option for a patient to receive standard of care outside of study involvement is described differently to the standard of care they would receive in New Zealand.

The Committee noted the importance of accurate information and thus the standard of care being described accurately relating to a New Zealand context otherwise PIS/CF is unhelpful to both patients and investigators in the informed consent discussion.

The Committee queried whether PET scanning was standard treatment. Ms Thomas clarified that this was not standard treatment and is a recent addition to the scans available.

The Committee queried if there were further CT scanning for participants. Ms Thomas confirmed that the CT scans did not deviate from standard care. The number of CT scans is typical for standard treatment for early stage breast cancer.

The Committee queried if the timing of the scans was appropriate. Ms Thomas explained the time limits for the scans, noting the PET scans must be done prior to the biopsy being taken. This involves a ~4 day window. There have been discussions to ensure these timeframes can be met with no additional risk for participants.

The Committee queried if the window is missed whether the participants may have an additional CT scan. Ms Thomas explained there could be an instance where participants may not be able to attend but it is very unlikely. If this does occur the researcher will contact the sponsor to fill out a protocol deviation.


The Committee confirmed the participants will not have any further radiation involved other than what is described in the PIS/CF and standard treatment.

The Committee queried whether it would be possible to have an additional PIS for ‘all’ future unspecified research to distinguish what is required for the study and what is not, noting the genetic testing was taken out as a separate form but the ‘future research’ was included in the main PIS. The committee suggested making the ‘future’ research optional and removing it from the main PIS.

Committee requested clarification on how study may reduce health inequalities (F.1.1). Ms Thomas explained that all eligible patients, irrespective of their ethnicity, who met all inclusion / exclusion criteria, will be eligible to participate. Ms Thomas noted that Maori have higher incidents of late presentation of cancer. If we are able to capture them early there is a belief that not only Maori but all patients will benefit.

The Committee noted that the study will not specifically address inequalities but will help all eligible participants, noting that Maori may be disproportionately affected.

The Committee queried the compensation statement – the committee suggested using the wording in the new PIS/CF template you can find it at: http://ethics.health.govt.nz/system/files/documents/pages/PISCF-templates-June3013.doc

Committee queried if biopsies are going to Germany. Ms Thomas explained that samples will be sent to Germany and then sent to Spain. Ms Thomas confirmed the samples will be stored in Spain however was unsure about what was occurring in Germany. The Committee noted the PIS states that tests samples will be stored in a tissue bank in Spain.

The Committee requested the PIS includes information about samples being tested and stored in European countries to ensure participants are aware of what is happening to their tissue and that this may occur in more than one overseas location.

The Committee suggested being careful about claiming that people who participate in clinical trials have better health outcomes.


o Add who is funding the study (NOVARTIS) pg.15.o Remove reference to Australian national statement.o Remove the word ‘endorsed’ from the review of the PIS.o Remove repeated sentence (second paragraph down pg.4)o Please address repetition (additional costs for participation in the study pg.6)o Include accurate information on standard treatment in New Zealand and

options for treatment outside of study involvement. It is a fundamental requirement of informed consent that participants know their options and have accurate information available to them.

Decision



Please provide a separate Participant Information Sheet and Consent Form for the use of tissue for future unspecified research (Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes, para 2).


The above information will be reviewed, and a final decision made on the application, by Mrs Stephanie Pollard and Ms Raewyn Sporle.


5 Ethics ref: 13/NTB/147Title: Zoledronic acid in DMDPrincipal Investigator: Dr Craig JefferiesSponsor:Clock Start Date: 19 September 2013

Dr Craig Jefferies was not present for discussion of this application.






The Committee noted that the peer review document uploaded. Peer review needed to address the methodology of the study and is not sufficient to meet the condition for favourable peer review. The Committee requested the original review provided by the Muscular Dystrophy Association or something similar.

Provide the terms of reference for the DSMB (R.1.5). Please explain if there may be incidental findings related to the blood tests and if there are

findings unrelated to the study please provide processes in place to manage the findings (R.4.1).

Please justify the lack of Maori consultation noting the HRC guidelines state that if Maori will participate in a study then some form of Maori consultation will be appropriate.

Explain how ethnicity data will be collected (P.4.6). Committee suggests using the New Zealand Census question to ensure the data collection is appropriate for New Zealand participants.

Please explain how study will explicitly reduce inequalities as per answer given in application. The committee notes that the study does not have the potential to address inequalities (F.1.1.).

Clarify the statement made regarding ethical safety and moral issues as reasons for excluding groups (F.2.2).

Committee queried the need for a witness on the CF as this is not required. The Committee discussed the age of the participants and decided the PIS for children 6-

11 years old is not suitable for a 6 year old. Please consider using the 6-11 year old PIS for the 12-16 year olds and then rewrite the

6-11 year old PIS using simple, age appropriate language. The Committee suggested having a volunteer from the age group read the document and

relay their understanding to ensure the document is effective. The Committee queried what process was in place to consent participants once they turn

16 and can legally consent, and whether they are able to withdraw their data or be approached to consent (if turning 16 outside of the two year study treatment period).

Please clarify whether any of the additional supplements (calcium, Vit D, phosphate) involved have any associated risks and if so make this clear on the PIS.

Please explain if there was consideration given to excluding children who have recently had dental surgery or have any planned for the study duration.


The Committee queried whether there were any dental guidelines for children receiving Zoledronic acid. If there are any specific measures, for example provision of information on dental hygiene or a statement such as ‘please inform investigator should you require dental surgery at any time’ then please add this to PIS’.

Committee notes quality of life has been added as an additional aim. Please confirm how quality of life is measured.

The Committee queried if annual back x-rays are part of standard treatment in New Zealand. If not – please justify additional radiation risk.


o Please remove reference to Australian law (pg.7).o Revisit sentence two on section 1 (pg.1).o Please include information on ACC coverage on Section 10 (pg.7).o Include intention to inform health practitioners.o Ensure correct HDEC (Northern B) is detailed on Section 13 (pg.8).o Please describe what an IV infusion is for participants in lay language.o Please ensure footer and header match in relation to version numbers for

parent CF.o Please avoid reference to Australia – if approved in New Zealand please

amend.o Please include information in the PIS/CF that the samples stored may be used

for future unspecified research.o Please ensure the child is referred to throughout the parent PIS as ‘your child’

not ‘you’. The child is the participant.o Please advise participants that they will have to inform the Co-ordinating

Investigator if they are planning to have dental surgery during the 2 years of study involvement.

o Would the ‘osteonecrosis’ risk be able to be quantified for participants in this study, noting the dose given is presumably different to that for adult osteoporosis.

Decision



Please provide evidence of favourable independent peer review of the study protocol (Ethical Guidelines for Intervention Studies Appendix 1).

Provide details of the Data Safety Monitoring Committee’s composition and monitoring plan (Ethical Guidelines for Intervention Studies para 6.50).

The above information will be reviewed, and a final decision made on the application, by Ms Kerin Thompson and Ms Mary-Anne Gill.


6 Ethics ref: 13/NTB/148Title: A study to Evaluate the Safety, Tolerability, and Activity of

NGM282 in patients with Type 2 Diabetes.Principal Investigator: Dr Ajith DissanayakeSponsor: NGM Biopharmaceuticals, Inc.Clock Start Date: 19 September 2013

Ms Catherine Howie (Primary Contact) and Dr John Baker (Co-Investigator) were present by teleconference for discussion of this application.






The Committee queried if the agent being tested was manufactured or was from an animal source. The Researchers clarified it was manufactured.

The Committee commended the clarity of the protocol. The Committee queried the number of hours patients will be monitored after treatment.

The Researcher clarified a minimum of 2 and maximum of 4 hours. Committee queried who is responsible for safety oversight for all data across all sites. The

Researchers explained that there is no formal DSMC but a medical monitor would review data as it comes through, including SAEs. The Researcher has queried if this level of monitoring is sufficient with the Sponsor The committee would like sponsor to provide justification for the absence of a DSMB, noting that this is unusual and would generally be expected in an early phase study.

The Committee noted the trial Co-ordinator was recruiting participants. The Committee asked how the potential conflict of interest would be mitigated, as the trial co-ordinator has a vested interest in recruiting participants into the trial. The Committee suggested giving patients time to consider study involvement outside of the clinic environment. Ms Howie confirmed this measure was already in place.

Please explain the reimbursement rationale (P.3.3.1). The Researchers explained the figure was about $110 dollars per visit.

Please explain why patients with alcoholism or drug addiction are excluded. Researcher explained this was a company policy and it related to potential unreliability of participants.

The committee queried if there were rescue strategies in place. The Researcher explained that the participants will be monitored during the wash out period, so if participants suffer symptoms the participants will be addressed. If the participants fall out of the inclusion criteria due to these complications they will not participate in the study and will be provided with rescue therapy.

The Committee queried the fasting requirements before clinic appointments. The Committee asked what provisions were in place to assist the need to fast, such as food after the blood tests or being considerate of the clinic appointment times.

The Researcher explained that a 9 hour fast was standard (from 12am midnight) for patient’s not taking part in the study and this fast was just a couple hours longer. The Researchers confirmed food would be offered after testing. Researcher confirmed


medication is not to be taken on day of these fasting visits but will be given to patient in clinic.

The researcher explained that the HEP B exclusion was related to liver damage but it was not clear why HIV was an exclusion criterion. Researcher will follow up with sponsor to clarify.


o Please make it clear to participants that anaphylaxis is a theoretical concern and has not been observed in relation to study drug (pg.7).

o Please change ethics committee to Northern B (pg.14)o Include reasons why positive result for HIV / HEP B results in exclusion from

participation.o Reword ‘authorisation form’ to consent on the second to last bullet point

(pg.13).o The Committee suggested changing ‘homeostasis’ to ‘equilibrium’.o Please ensure the explanation of double blind is specific to the trial, in that it

explains what will occur, rather than a generic description of what a double blind is.

o Last 6 bullet points (in the box) – why are these optional? Researcher explained that if participants were not willing to consent to these options they will not be eligible for the study. Please ensure mandatory requirements are not yes/no.

o Remove termination criteria relation to commercial interests. Studies should not be terminated for commercial reasons (pg.9).

o Australian information on ethics committees – please change to HDEC and remove Australian national statement (pg.12).

o The Committee queried the contradiction between taking medication at same time (after breakfast) every day compared to test days (where they are asked to fast). Please make the difference in medication times for test days explicit.

Decision



Provide justify lack of Data Safety Monitoring Committee (Ethical Guidelines for Intervention Studies para 6.50).

Revisit the exclusion criteria relating to Hep B and HIV (Ethical Guidelines for Intervention Studies para 4.5).

The above information will be reviewed, and a final decision made on the application, by Dr Paul Tanser and Ms Mary-Anne Gill.


7 Ethics ref: 13/NTB/151Title: Chart review of renal biopsies in type 2 diabetic patientsPrincipal Investigator: Dr Jasmine TanSponsor:Clock Start Date: 19 September 2013

Dr Jasmine Tan was present by teleconference for discussion of this application.






The Committee queried whether the study was an audit. The researcher feels the design is more like an audit noting it involved human tissue.

The Committee queried what will happen with the renal biopsies. Researcher explained that a pathologist will access patient information and to identify the tissue, review the tissue and make an independent assessment of the pathological finding using slides already available.

The biopsy is being ‘read’ rather than ‘tested’. There will be no further data derived from the observation and no further tests conducted on tissue.

Initially data is ‘de-identified’. Dr Tan confirmed NHI is entirely removed after analysis and thus all data becomes anonymous. .

Decision

This application was approved by consensus.


General business

1. The Committee noted the content of the “noting section” of the agenda.

2. Mrs Stephanie Pollard and Ms Kerin Thomson raised a conflict for an application that is coming to the November NTB meeting “Retrospective tissue collection and genomic analysis of neuroendocrine tumours for clinical tests”.

3. The Chair reminded the Committee of the date and time of its next scheduled meeting, namely:

Meeting date: 05 November 2013, 12:00 PM

Meeting venue: Novotel Ellerslie, 72-112 Greenlane Rd East, Ellerslie, Auckland

The following members tendered apologies for this meeting.

4. Problem with Last Minutes

The minutes of the previous meeting were agreed and signed by the Chair and Co-ordinator as a true record.

The meeting closed at 3.37pm


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